Last updated: 11/03/2018 22:14:22

Efficacy of Topical Indomethacin Patch over Placebo in Ankle Sprain Pain relief

GSK study ID
202177
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Clinicaltrials.gov ID
NCT01957215
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Clinical Study to Assess the Efficacy of Pain Relief of Topical Indomethacin Patch over Placebo in Ankle Sprain Patients
Trial description: This study will investigate the efficacy of the Indomethacin patch in pain relief of ankle sprain in adult patients, compared to a placebo patch
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Sum of Pain Intensity Difference (SPID)1-3 days

Timeframe: Baseline (Day 1) to Day 3

Secondary outcomes:

Pain Relief Score (PRS) on movement over time

Timeframe: 30 minutes (mins) to 144 hours (hrs) post treatment

NRS for pain on movement over time

Timeframe: 30 mins to 144 hr post treatment

Change from baseline in NRS at rest

Timeframe: Baseline (Day 1) to Day 7

Time to onset of pain relief

Timeframe: Baseline (Day 1) to Day 3

Assessment of Sum of Pain Intensity Difference (SPID) on movement

Timeframe: Baseline (Day 1) to Day 7

Sum of Pain Intensity Difference and Pain Relief (SPRID) on movement

Timeframe: Baseline (Day 1) to Day 7

Total Pain Relief (TOTPAR) on movement

Timeframe: Baseline (Day 1) to Day 7

Patients' global assessment to treatment

Timeframe: Baseline (Day 1) to Day 14

Rate of rescue medication use

Timeframe: Baseline (Day 1) to Day 14

Time to first dose of rescue medication use

Timeframe: Baseline (Day 1) to Day 14

Total dose of rescue medication use

Timeframe: Baseline (Day 1) to Day 14

Interventions:
  • Drug: Indomethacin
  • Drug: Placebo
    • Enrollment:
    270
    Primary completion date:
    2014-14-09
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Ankle Sprain
    Product
    indometacin
    Collaborators
    Rundo International Pharmaceutical Research & Development Co., Ltd
    Study date(s)
    October 2013 to September 2014
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    No
    • Participant with Grade I or Grade II acute sprain of the lateral ankle within 24 hours before screening visit
    • Participant with self-assessed pain intensity score after movement (5 steps) at the site of the ankle sprain that is >= 5 as measured on a 0-10 NRS rating.
    • Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
    • Participant who had medication that could interfere with the subject’s perception of pain since experiencing ankle sprain.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Participant with Grade I or Grade II acute sprain of the lateral ankle within 24 hours before screening visit
    • Participant with self-assessed pain intensity score after movement (5 steps) at the site of the ankle sprain that is >= 5 as measured on a 0-10 NRS rating.
    • Participant with a peri-malleolar edema (sub-malleolar perimeter difference of >=20mm between injured and uninjured ankle)
    Exclusion criteria:
    • Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
    • Participant who had medication that could interfere with the subject’s perception of pain since experiencing ankle sprain.
    • Pregnancy , Breast Feeding and Substance Abuse

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    Shanghai First People's Hospital
    Shanghai, Shanghai, China, 201620
    Status
    Study Complete
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    Location
    Shanghai East Hospital
    Shanghai, Shanghai, China, 200120
    Status
    Study Complete
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    Location
    Zhongda Hospital Southeast University
    Nanjing, Jiangsu, China, 210009
    Status
    Study Complete
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    Location
    Shanghai First People?s Hospital
    Shanghai, Shanghai, China, 201620
    Status
    Recruiting
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    Location
    Changzhou NO.2 People?s Hospital
    Changzhou, Jiangsu, China, 213003
    Status
    Recruiting
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    Location
    The First Affiliated Hospital of Soochow University
    Suzhou, Jiangsu, China, 215006
    Status
    Study Complete
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    Showing 1 - 6 of 16 Results

    Study documents

    Statistical analysis plan
    Available language(s): English
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    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2014-14-09
    Actual study completion date
    2014-14-09

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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